tag:blogger.com,1999:blog-3642436624513973162024-03-04T22:00:47.998-08:00PharmabragThis is the space where I jot down my observations on the healthcare industryThe Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.comBlogger26125tag:blogger.com,1999:blog-364243662451397316.post-59691700516319054232016-08-28T03:35:00.000-07:002016-09-07T03:35:53.273-07:00Trastuzumab marketing approval may come in 12-18 months: Biocon <div dir="ltr" style="text-align: left;" trbidi="on">
<span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">Shares of </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Biocon" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">Biocon </a><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">hit a fresh record high of Rs 910, up 5% on the BSE in early morning trade, after the company announced Mylan’s application to market </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Biosimilar" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">biosimilar</a><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Trastuzumab" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">Trastuzumab </a><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">has been accepted by the </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=European+Medicines+Agency" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">European Medicines Agency </a><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">(EMA) for review. The </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Biosimilar" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">biosimilar</a><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Trastuzumab" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">Trastuzumab </a><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">is used to treat certain breast and gastric cancers.</span><br style="background-color: white; box-sizing: border-box; font-family: "Open Sans", sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><br style="background-color: white; box-sizing: border-box; font-family: "Open Sans", sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">“Mylan and Biocon, which have co-developed this popular biosimilar, anticipate that this may be the first Marketing Authorization Application (MAA) for a </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Biosimilar" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">biosimilar</a><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Trastuzumab" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">Trastuzumab </a><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">accepted by the </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Ema" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">EMA </a><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">for review,” Mylan and</span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Biocon" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">Biocon </a><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">said in a joint press release.</span><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;"></span><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;"></span><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;"></span><br />
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<br style="background-color: white; box-sizing: border-box; font-family: "Open Sans", sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><br style="background-color: white; box-sizing: border-box; font-family: "Open Sans", sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">“This is the second </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Biosimilar" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">biosimilar </a><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">submission developed by the partnership that has been accepted for review in Europe,” it added.</span><br style="background-color: white; box-sizing: border-box; font-family: "Open Sans", sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><br style="background-color: white; box-sizing: border-box; font-family: "Open Sans", sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">The filing includes analytical, functional and pre-clinical data and results from the pharmacokinetics and confirmatory safety global clinical trials for Trastuzumab, the company said.</span><br style="background-color: white; box-sizing: border-box; font-family: "Open Sans", sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><br style="background-color: white; box-sizing: border-box; font-family: "Open Sans", sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;">At 09:29 am, the stock was up 4.7% at Rs 906 on the BSE, as compared to 0.29% rise in the S&P BSE Sensex. The counter has seen huge trading volumes with a combined 1.26 million equity shares changing hands in first 15 minutes of trade on the NSE and BSE.</span><br style="background-color: white; box-sizing: border-box; font-family: "Open Sans", sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><span style="background-color: white; font-family: "Open Sans", sans-serif; font-size: 15px; line-height: 24px;"> </span></div>
The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-21183606197494136732016-07-15T04:15:00.000-07:002016-09-07T04:15:47.879-07:00Biocon's partner firm launches diabetes product in Japan <div dir="ltr" style="text-align: left;" trbidi="on">
<span style="background-color: white; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">NEW DELHI: Biocon today said its partner Fujifilm Pharma Co has launched its biosimilar product Insulin Glargine in Japan after receiving approval from the Japanese health authority earlier this year. </span><br style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: Arial, Helvetica, sans-serif; font-size: 12px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;" /><br style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: Arial, Helvetica, sans-serif; font-size: 12px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;" /><span style="background-color: white; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">"Close on the heels of receiving approval for its Insulin Glargine from the Japanese regulator last year, its partner Fujifilm Pharma Co has launched the product in Japan today," Biocon said in a BSE filing. </span><br style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: Arial, Helvetica, sans-serif; font-size: 12px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;" /><br style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: Arial, Helvetica, sans-serif; font-size: 12px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;" /><span style="background-color: white; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">In March this year, Biocon received approval from the Japanese he .. </span><br style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: Arial, Helvetica, sans-serif; font-size: 12px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;" /><br />
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-85727095893898718192016-07-12T03:37:00.000-07:002016-09-07T03:56:21.486-07:00Syngene International gains after kicking off new development center in Bangalore<div dir="ltr" style="text-align: left;" trbidi="on">
<div style="background-color: white; box-sizing: border-box; font-size: 15px; line-height: 24px; margin-bottom: 12px !important; padding: 2px 0px !important;">
<span style="font-family: "helvetica neue" , "arial" , "helvetica" , sans-serif;">Syngene International rose 2.70% to Rs 485.10 at 9:31<span class="btn_bg activator" id="Ist" style="background-color: #f8e2d7; background-position: 100% 50%; background-repeat: no-repeat; border-radius: 2px; box-sizing: border-box; color: #2591dc; cursor: pointer; padding: 1px 20px 1px 6px;">Ist</span>on <span class="btn_bg activator" id="Bse" style="background-color: #f8e2d7; background-position: 100% 50%; background-repeat: no-repeat; border-radius: 2px; box-sizing: border-box; color: #2591dc; cursor: pointer; padding: 1px 20px 1px 6px;">Bse</span>after the company announced the establishment of an integrated, multi-disciplinary drug discovery and development center for Amgen, Inc in Bangalore, India.</span></div>
<span style="background-color: white; font-size: 15px; line-height: 24px;"><span style="font-family: "helvetica neue" , "arial" , "helvetica" , sans-serif;">The announcement was made after market hours yesterday, 6 September 2016.</span></span><br />
<div style="background-color: white; box-sizing: border-box; font-size: 15px; line-height: 24px; margin-bottom: 12px !important; padding: 2px 0px !important;">
<span style="font-family: "helvetica neue" , "arial" , "helvetica" , sans-serif;">Meanwhile, the <span class="btn_bg activator" id="Bse" style="background-color: #f8e2d7; background-position: right center; background-repeat: no-repeat; border-radius: 2px; box-sizing: border-box; color: #2591dc; cursor: pointer; padding: 1px 20px 1px 6px;">Bse</span>Sensex was down 24.83 points, or 0.09%, to 28,953.19.</span></div>
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<span style="font-family: "helvetica neue" , "arial" , "helvetica" , sans-serif;">On BSE, so far 8,396 shares were traded in the counter, compared with average daily volume of 26,251 shares in the past one quarter. The stock hit a high of Rs 494.05 and a low of Rs 477.90 so far during the day. The stock hit a record high of Rs 486 on 31 August 2016. The stock hit a 52-week low of Rs 315 on 23 September 2015. The stock had outperformed the market over the past 30 days till 6 September 2016, rising 12.76% compared with 2.82% rise in the Sensex. The scrip had also outperformed the market in past one quarter, rising 23.25% as against Sensex's 7.24% rise.</span></div>
<div style="background-color: white; box-sizing: border-box; font-size: 15px; line-height: 24px; margin-bottom: 12px !important; padding: 2px 0px !important;">
<span style="font-family: "helvetica neue" , "arial" , "helvetica" , sans-serif;">The mid-cap company has equity capital of Rs 200 crore. Face value per share is Rs 10.</span></div>
<div style="background-color: white; box-sizing: border-box; font-size: 15px; line-height: 24px; margin-bottom: 12px !important; padding: 2px 0px !important;">
<span style="font-family: "helvetica neue" , "arial" , "helvetica" , sans-serif;">This center, named Syngene Amgen Research and Development Center (SARC), will be Syngene's fourth such exclusive R&D center. Syngene already operates dedicated R&D centers for Bristol-Myers Squibb, Abbott Nutrition and Baxter Inc. The state-of-the-art dedicated center will be staffed by a team of more than 100 highly qualified Syngene scientists, working in close association with Amgen researchers around the world on the discovery and development of innovative medicines.</span></div>
<div style="background-color: white; box-sizing: border-box; font-size: 15px; line-height: 24px; margin-bottom: 12px !important; padding: 2px 0px !important;">
<span style="font-family: "helvetica neue" , "arial" , "helvetica" , sans-serif;">In addition to being customized to meet Amgen's functional requirements, the facility complies with the highest regulatory standards. Its design includes a range of environmentally-friendly features and flexible layouts, and is configured to minimize solvent and effluent waste with a strong emphasis on laboratory safety and green chemistry. Syngene has partnered with Amgen in a variety of discovery and development projects. With the establishment of SARC, this association now extends into a multi-discipline collaboration spanning capabilities in medicinal and process chemistry, biologics, bioprocess, drug metabolism, pharmacokinetics, bioanalytical research, and pharmaceutical development.</span></div>
<div style="background-color: white; box-sizing: border-box; font-size: 15px; line-height: 24px; margin-bottom: 12px !important; padding: 2px 0px !important;">
<span style="font-family: "helvetica neue" , "arial" , "helvetica" , sans-serif;">Net profit of Syngene International rose 28.33% to Rs 59.80 crore on 17.92% rise in net sales to Rs 269.20 crore in Q1 June 2016 over Q1 June 2015.</span></div>
<div style="background-color: white; box-sizing: border-box; font-size: 15px; line-height: 24px; margin-bottom: 12px !important; padding: 2px 0px !important;">
<span style="font-family: "helvetica neue" , "arial" , "helvetica" , sans-serif;">Promoted by Biocon, Syngene International is a leading India-based contract research organization (CRO) offering a suite of integrated and end-to-end discovery and development services for novel molecular entities (NMEs) across industrial sectors. Biocon holds 74.55% stake in Syngene, as per the shareholding pattern as on 30 June 2016.</span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-17974734330232363162016-06-06T04:09:00.000-07:002016-09-07T04:11:23.810-07:00Biocon, Quark get DCGI nod for trials of new eye disease drug <div dir="ltr" style="text-align: left;" trbidi="on">
<span style="background-color: white; font-family: "arial" , "helvetica" , sans-serif; font-size: 12px;">Biopharmaceutical firm Biocon today said the Drug Controller General of India (DCGI) has given nod to it and partner Quark Pharmaceuticals to proceed with clinical trials on human subjects for a new drug candidate, 'QPI-1007' aimed for ocular neuroprotection. </span><br />
<br style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: Arial, Helvetica, sans-serif; font-size: 12px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;" />
<span style="background-color: white; font-family: "arial" , "helvetica" , sans-serif; font-size: 12px;">Biocon and Quark Pharmaceuticals also announced the randomisation of the first patient in India in the global Phase II/III study of the new drug candidate, the company said in a statement. </span><br />
<br style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: Arial, Helvetica, sans-serif; font-size: 12px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;" />
<span style="background-color: white; font-family: "arial" , "helvetica" , sans-serif; font-size: 12px;">Randomisation is the allo .. </span><br />
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Read more at:<br />
<a href="http://economictimes.indiatimes.com/articleshow/52881320.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst" style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; color: #024d99; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">http://economictimes.indiatimes.com/articleshow/52881320.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst</a></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-19402943048109742042016-06-06T03:53:00.000-07:002016-09-07T03:57:20.320-07:00Biocon cancer drug trial data positive from 3 clinical trials <div dir="ltr" style="text-align: left;" trbidi="on">
<span style="background-color: white; font-family: "arial" , "helvetica" , sans-serif; font-size: 12px;">MUMBAI: Indian biotech frontrunner Biocon and its global partner for biosimilars, Mylan, have announced positive data from phase 3 clinical trials of a proposed copy of trastuzumab, a complex injection used widely to treat a type of breast cancer. </span><br />
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<span style="background-color: white; font-family: "arial" , "helvetica" , sans-serif; font-size: 12px;">The trial results, being presented this week at the American Society of Clinical Oncology - a prestigious conference held annually in the US —gives the drugmakers an edge over rivals and will enable regulatory submissions for commercial la .. </span><br />
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-35498268077878521762015-09-26T13:52:00.003-07:002015-09-26T13:52:43.716-07:00Pharma tycoons climb as stocks zoom<div dir="ltr" style="text-align: left;" trbidi="on">
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Over a dozen people from pharmaceuticals and healthcare industry made it to the Forbes list of India's 100 Richest People.</div>
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Apart from the second richest Indian <a href="http://www.dnaindia.com/topic/dilip-shanghvi">Dilip Shanghvi</a> of Sun Pharmaceutical Industries (net worth $18 billion), the list includes vaccine king Cyrus Poonawala (net worth $7.9 billion) who owns Serum Institute of India, who made it to the top ten, Desh Bandhu Gupta (net worth of $5.9 billion) of Lupin, Pankaj Patel ($4.1 billion) of Cadila Healthcare, Yusuf Hamied ($3 billion) of Cipla, PV Ramprasad Reddy ($2.8 billion) of Aurobindo Pharma, Reddy Family ($2.6 billion) of Dr Reddy's Laboratories, Samprada Singh ($2 billion of Alkem Laboratories) and Glenn Saldanha ($2 billion) of Glenmark.</div>
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Forbes in its list said Dilip Shanghvi's wealth flatlined as Sun Pharma reported a 46% drop in net profit due to merger costs linked to acquisition of rival Ranbaxy Industries.</div>
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The list of 100 people also saw Leena Tiwari of USV Pharma, Mannalal Agarwal of <a href="http://www.dnaindia.com/topic/ajanta-pharma">Ajanta Pharma</a> and <a href="http://www.dnaindia.com/topic/chirayu-amin">Chirayu Amin</a> of Alembic Pharmaceuticals making an entry with net worths of $1.9 billion, $1.4 billion and $1.2 billion, respectively.</div>
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Both Mannalal Agrawal and Chirayu Amin debut on list after shares of Ajanta Pharma more than doubled in the past year, while that of Alembic Pharmaceuticals rose 66% in the past 12 months on the back of higher revenues and profits.</div>
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The list includes Rajendra Agarwal of Macleod's Pharmaceuticals, Habil Khorakiwala of Wockhardt, <a href="http://www.dnaindia.com/topic/ajay-piramal">Ajay Piramal</a> of Piramal Enterprises, Malvinder and Shivinder Singh of Fortis, all with net worths of $1.8 billion. It also lists B R Shetty ($1.7 billion) of UAE-based NMC Healthcare, Dilip and Anand Surana ($1.6 billion) of Micro Labs, Ramesh Juneja ($1.5 billion) of Mankind Pharma and Azad Moopen ($1.5 billion) of <a href="http://www.dnaindia.com/topic/aster">Aster</a> DM Healthcare.<br /> </div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-49015891200551630902015-09-26T13:47:00.001-07:002015-09-26T13:47:33.363-07:00Sun Pharma arm suffers US jolt<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: Georgia, "Times New Roman", serif;">In a setback to Sun Pharma Advanced Research Company (SPARC), the US Food and
Drug Administration (USFDA) has revoked an approval for its anti-epileptic drug
because of manufacturing quality concerns at the Halol plant of Sun
Pharmaceutical Industries.
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<span style="font-family: Georgia, "Times New Roman", serif;">SPARC is the research & development arm of Sun Pharma and it has plans to
manufacture the drug at the Halol facility. It may be recalled that the US drug
regulator had earlier observed certain current good manufacturing practices
(cGMP) deviations at the unit.</span></div>
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<span style="font-family: Georgia, "Times New Roman", serif;">SPARC had received a final approval from the USFDA in March this year for the
product and it was evaluating several marketing partners for the product.</span></div>
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<span style="font-family: Georgia, "Times New Roman", serif;">However, in a communication to the bourses today, the company said that the
US drug regulator has issued a complete response letter to its new drug
application for the anti-epileptic drug, indicated for adjunctive therapy in the
treatment of partial onset seizures in patients 12 years of age and older with
epilepsy.</span></div>
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<span style="font-family: Georgia, "Times New Roman", serif;">"SPARC has now received a letter from the USFDA rescinding its earlier
approval, citing that the compliance status of the manufacturing facility was
not acceptable on the date of approval,'' it said.</span></div>
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<span style="font-family: Georgia, "Times New Roman", serif;">Under the USFDA website, complete response letters are issued when
communicating a decision to a drug company that its new drug application or
abbreviated new drug application to market a new or generic drug will not be
approved in its present form.</span></div>
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<span style="font-family: Georgia, "Times New Roman", serif;">SPARC said Sun Pharma is working with USFDA in resolving the cGMP deviations
at the facility and has taken several corrective measures.</span></div>
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<span style="font-family: Georgia, "Times New Roman", serif;">In a presentation this June, SPARC had said that the market for the drug in
the US is at 720 million units and is growing at 5 year compounded annual growth
rate (CAGR) of 9 per cent. It had forecast that opportunity exists to market
Elepsia XR at significant premium to generics. Commercialisation of the drug in
the US market was slated in the second half of this fiscal.</span></div>
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<span style="font-family: Georgia, "Times New Roman", serif;">Under new regulations, USFDA's Center for Drug Evaluation and Research (CDER)
no longer issues "approvable" or "not approvable" letters when a drug
application is not approved. Instead, CDER issues a "complete response" letter
at the end of the review period to let a drug company know of the agency's
decision on the application.</span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-32618926420040096172015-08-25T21:30:00.000-07:002015-08-25T21:30:04.396-07:00Glenmark to focus on dermatology medication<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: Georgia, Times New Roman, serif;">Mumbai-based Glenmark Pharmaceuticals Ltd will focus on developing medications for ailments relating to cardiology, dermatology and respiratory conditions.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Speaking on the sidelines of the launch of Diabetes treatment drugs using Teneligliptin-based drugs Ziten and Zita Plus, Sujesh Vasudevan, President and Head – India Business, Glenmark Pharmaceuticals, said dermatology is one of the fastest-growing areas as more people are giving importance to beauty and wellness.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">“Though the products are sold based on prescription, people are increasingly opting for dermatology and cosmetology clinics because of the trust factor in the doctors rather than over-the-counter beauty products,” Vasudevan said.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">The company will also be launching Teneligliptin and Metformin combination product, which is currently under clinical trials at 30 centres.</span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-60051760986222262752015-08-25T21:25:00.001-07:002015-08-25T21:25:42.027-07:00Glenmark expecting USFDA nod for 4-6 products this fiscal <div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: Georgia, 'Times New Roman', serif; font-size: 12px; line-height: 12px;">We are expecting approvals for 4-6 products from the USFDA during this year," Glenmark Pharmaceuticals President and Head-India Business Sujesh Vasudevan told reporters here on the sidelines of launch of Teneligliptin in Telangana. The company had already got approvals for eight products this year, he added. Teneligliptin, a new third generation oral anti-diabetic agent, is used for the management of Type 2 Diabetes Mellitus. Glenmark has launched this molecule under two brands, Ziten and Zita Plus, at Rs 19.90 per tablet. "The launch of these two products will lower the daily cost of treatment for a diabetes patient on Gliptin therapy by approximately 55 percent," Vasudevan said. Glenmark's diabetes segment is valued at around Rs 100 crore, Vasudevan said, adding it is growing at 20 percent per annum. Reacting to a query, he said, "The capex for this year is Rs 600 crore and majority of this will go for the plant in the US."</span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-8760816676040779632015-08-25T21:21:00.003-07:002015-08-25T21:21:38.112-07:00Glenmark to launch 10-12 new products in India, eyes 18-20 per cent growth<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="background-color: white; font-family: Georgia, 'Times New Roman', serif; font-size: 12px;">Mumbai headquartered drug firm Glenmark Pharmaceuticals proposes to launch 10-12 new products in the domestic market during the current financial year (2015-16) and hopes to report a growth of 18-20 per cent, said a top official. </span></div>
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The Rs 6,600 crore firm in revenues last fiscal, earns over a fourth of revenues from the domestic market, mostly focusing on dermatology and diabetes drugs. The company may also look at acquiring brands or companies aimed at strengthening its market share in t .. </div>
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<span style="background-color: white; font-family: Georgia, 'Times New Roman', serif; font-size: 12px;">We are going to launch 10-12 new products in India this year. We have already launched 4 products so far. New product launches would help us maintaining the high growth rate at around 18-20 per cent when the industry is growing at about 12 per cent", said Vasudevan while addressing journalists in Hyderabad on Monday on the eve of launching new oral drug Teneligliptin for type-2 diabetes. </span></div>
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Glenmark, which currently earns around Rs 100 crore from the diabetes segment with a year on year growth of around 20 per cent, is planning to grow significantly with the help of new product launches going forward. </div>
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"Our new combination drug of tenegliptin and metformin is under clinical trials now. We will launch this product once we get the approvals from the authorities", said Sujesh. </div>
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He said the domestic diabetes drugs market is currently estimated at around Rs 6,600 crore and gliptins account for around Rs 1,200 crore. </div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-27389362137714960722015-08-20T08:29:00.000-07:002015-08-23T08:30:05.083-07:00Neutral rating on Cipla, Sun Pharma no game changer: Sarabjit Kour Nangra, Angel Broking, Pharma <div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="http://economictimes.indiatimes.com/thumb/msid-48556596,width-310,resizemode-4/pharma-2.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="http://economictimes.indiatimes.com/thumb/msid-48556596,width-310,resizemode-4/pharma-2.jpg" /></a></div>
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<em style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: Georgia, 'Times New Roman', serif; font-size: 12px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">In an interview with ET Now, Sarabjit Kour Nangra, VP - Research, Angel Broking, Pharma, shares his views on markets. Excerpts: </em></div>
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<span style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">ET Now: What is that you have made of the USFDA approval for Lupin for a drug of the Goa plant and does Lupin become a buy right now?</span><span style="background-color: white;"> </span></div>
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<span style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-size: 12px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><div style="text-align: justify;">
<span style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Sarabjit Kour Nangra: </span><span style="background-color: white;">This is definitely positive because we expect that Goa facility is not a big issue. It is just a few observations which have come in and we believe that </span><span style="background-color: white;">that it is positive because it indicates that probably they will overcome it. We have a neutral rating on the stock. We do not think the current valuations justify a buy rating on the stock. </span></div>
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<span style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-family: Georgia, 'Times New Roman', serif; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">ET Now: What about Sun Pharma, do you think these two product approvals that they have got, how big an opportunity are those for Sun Pharma?</span><span style="background-color: white; font-family: Georgia, 'Times New Roman', serif;"> </span></div>
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<span style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; font-size: 12px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><div style="text-align: justify;">
<span style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;">Sarabjit Kour Nangra:</span><span style="background-color: white;"> It is a good opportunity in the sense it is a specialised generic, nonetheless it is a generic because the product is already generic and there are various copies available to the product, but since it is a variation, it is in a capsule form, most of the oral products are equivalent available </span><span style="background-color: white;">in the branded and generic market are in the form of tablets, so this is a capsule with a higher dosage. </span></div>
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So, for the Sun PharmaBSE 0.28 % given its competitive edge and given the efficacy of the product, it can easily do 80 to 50 million on a conservative basis to begin with and then scale up the product. As of now, it is not a game changer but it can be as the product scales up over a period of years. So, it is good news and the ANDA approval that they have got is also of decent size o it will add to the company but since the company is so big that such small approvals do not add significantly. </div>
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<span style="font-family: Georgia, Times New Roman, serif;">source: <a href="http://economictimes.indiatimes.com/articleshow/48556552.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst" style="background-attachment: initial; background-clip: initial; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; color: #024d99; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; vertical-align: baseline;">http://economictimes.indiatimes.com/articleshow/48556552.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst</a><span style="background-color: white;">.. </span></span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-24546697596687323282015-08-20T07:41:00.000-07:002015-08-23T07:42:04.877-07:00Sun Pharma, Lupin Surge on New Drug Approval<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="background-color: #e4e8e8; color: #333333; font-family: Georgia, 'Times New Roman', serif; font-size: 16px; line-height: 24px;">Sun Pharma and Lupin shares surged on Thursday in an otherwise weak market after both the companies got approval for new drugs from the US Food and Drug Administration (USFDA). The new drug approvals for Sun Pharma and Lupin can offer millions of dollars in revenues to these companies.</span></div>
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<span style="font-family: Georgia, 'Times New Roman', serif;">Analysts say, total annual revenues expected from the drug is about $154 million and the competition in this drug is limited to only three generic players.</span></div>
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<span style="font-family: Georgia, 'Times New Roman', serif;">Lupin has got approval to manufacture the drug from its Goa plant, which had got Form 483 (observation letter) from the USFDA in July. However, this approval indicates that observations at Goa plant are not disruptive and pushed its shares as much as 8.1 per cent higher.</span></div>
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<span style="font-family: Georgia, 'Times New Roman', serif;">Similarly, Sun Pharma shares advanced over 4 per cent after the pharma major received approval for generic drug Xenazine, which is used for treatment of acne.</span></div>
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<span style="font-family: Georgia, 'Times New Roman', serif;">Analysts say the market for Xenazine is around $319 million annually and Sun Pharma can expect sales of $6-7 million per month from this drug. Sun Pharma expects to launch this product in last quarter of 2015.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Lupin shares closed 5.30 per cent higher at Rs 1,890.55 and Sun Pharma shares ended 0.91 per cent higher at Rs 935.65 apiece, compared to 1.44 per cent loss in the broader Nifty.</span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-53296995429845484412015-08-20T07:32:00.000-07:002015-08-23T07:39:55.137-07:00Lupin's appetite for growth<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="background-color: white; font-family: Georgia, 'Times New Roman', serif;">It’s always a tough call for companies to decide on the need—or otherwise—for an acquisitions-led growth strategy. Oftentimes one has seen business owners examining the pros and cons of potential acquisitions and then going back to an organic growth strategy, keeping in mind current compulsions, cash flows and the impact an acquisition could have on the balance sheet. In this context, Lupin Ltd’s recent, and aggressive, acquisitions-driven growth recipe deserves special attention. The company, founded by Desh Bandhu Gupta in the ’60s, is India’s third largest pharma company by sales, and the next generation of the Gupta family—CEO Vinita and MD Nilesh—are currently busy implementing what is arguably one of the more aggressive buyouts-driven growth plans seen in the pharma sector. The target the two have set for themselves is daunting: A $5 billion turnover by FY2018. In rupee terms, it means the company will have to vault from a current turnover level of Rs 12,600 crore to Rs 31,875 crore in three years. And Lupin realises that if this has to happen, acquisitions would have to be an integral part of the company’s plans.</span></div>
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<span style="background-color: white; text-align: left;">The first big steps have already been taken in that direction. The company announced three important buys in July, which includes a hefty $880 million one of Gavis, an American generic drug maker, which has become the largest acquisition by an Indian pharma company, bigger than the Dr Reddy’s-Betapharm deal of over $560 million in 2006. The Gavis acquisition will provide Lupin a stronger foothold in the American market, which accounts for 45 percent of Lupin’s FY15 revenues, apart from bulking up its portfolio with specialised products. </span></div>
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<span style="font-family: Georgia;"><span style="text-align: left;"><br /></span><span style="background-color: white; text-align: left;">The Gavis buy, as Associate Editor Aveek Datta writes in the cover story, is an important piece of a broader ‘string of pearls’ strategy drawn up by the pharma major, whereby smaller companies will provide flanking support by way of a mix of specialised products, new markets and technologies. Not surprising then that the Guptas are already talking of further acquisitions to the tune of another $500-700 million over the next year. That the buyouts strategy has gathered serious momentum is also borne out by the fact that half of the 12 companies Lupin has acquired thus far have been bought over the past year-and-a-half. The strategy seems to have pleased shareholders, particularly billionaire investor Rakesh Jhunjhunwala, who has given the Guptas a firm thumbs-up.</span><br style="text-align: left;" /><span style="text-align: left;"><br /></span><span style="background-color: white; text-align: left;">This issue also brings you the coveted Forbes list of America’s Top 200 Colleges. The listing and the stories show that colleges and universities in the US are increasingly focusing on providing greater value to students, given the steep cost of higher education. And importantly, many are proving to be excellent launchpads for the next generation of entrepreneurs.</span><span style="text-align: left;"><br /><br />Source: </span></span><br />
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<a href="http://forbesindia.com/column/column/lupins-appetite-for-growth/40931/1#ixzz3jeHEgN1Q" style="color: #003399; text-decoration: none;">http://forbesindia.com/column/column/lupins-appetite-for-growth/40931/1#ixzz3jeHEgN1Q</a></span></span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-77666003164298629672015-08-19T21:38:00.000-07:002015-08-25T21:39:12.857-07:00Glenmark receives USFDA nod for oral contraceptive drug<div dir="ltr" style="text-align: left;" trbidi="on">
<span style="background-color: white; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px;">Glenmark Pharmaceuticals today said it has received final approval from the US health regulator to sell </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Oral+Contraceptive" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">oral contraceptive </a><span style="background-color: white; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px;">-- </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Drospirenone" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">drospirenone </a><span style="background-color: white; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px;">and </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Ethinyl+Estradiol" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">ethinyl estradiol </a><span style="background-color: white; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px;">tablets -- in the US market.</span><br style="background-color: white; box-sizing: border-box; font-family: 'Open Sans', sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><br style="background-color: white; box-sizing: border-box; font-family: 'Open Sans', sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><span style="background-color: white; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px;">"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Drospirenone and Ethinyl Estradiol tablets USP, 3 mg/0.02 mg," the company said in a BSE filing.</span><br style="background-color: white; box-sizing: border-box; font-family: 'Open Sans', sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><br style="background-color: white; box-sizing: border-box; font-family: 'Open Sans', sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><span style="background-color: white; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px;">The product is generic version Bayer's Yaz tablets.</span><br style="background-color: white; box-sizing: border-box; font-family: 'Open Sans', sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><br style="background-color: white; box-sizing: border-box; font-family: 'Open Sans', sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><span style="background-color: white; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px;">Glenmark said it plans to commence shipping of drospirenone and ethinyl Estradiol tablets immediately.</span><br style="background-color: white; box-sizing: border-box; font-family: 'Open Sans', sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><br style="background-color: white; box-sizing: border-box; font-family: 'Open Sans', sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><span style="background-color: white; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px;">Citing IMS Health sales data, the company said for the 12 months period ending June, "The Yaz market achieved annual sales of approximately $170.1 million".</span><br style="background-color: white; box-sizing: border-box; font-family: 'Open Sans', sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><br style="background-color: white; box-sizing: border-box; font-family: 'Open Sans', sans-serif; font-size: 15px; height: 0px !important; line-height: 24px; margin: 0px; padding: 0px;" /><span style="background-color: white; font-family: 'Open Sans', sans-serif; font-size: 15px; line-height: 24px;">Glenmark's shares were trading at Rs 1,213.65 apiece, up 4.62% from their previous close on BSE.</span></div>
The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-32322796867332987512015-08-13T04:55:00.000-07:002015-08-13T04:55:39.648-07:00Lupin pharmaceutical firm opens research center in Broward<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: Times, "Times New Roman", serif;">A pharmaceutical firm from India opened a $13 million facility in Coral Springs, where it plans to create 45 jobs.</span></div>
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<span style="font-family: Times, "Times New Roman", serif;">Mumbai, India-based Pharma Major Lupin received a $315,000 public incentive package in a deal with local officials and the state after working with the </span><a class="saveLink" href="http://www.bizjournals.com/profiles/company/us/fl/fort_lauderdale/greater_fort_lauderdale_alliance/1126456"><span style="font-family: Times, "Times New Roman", serif;">Greater Fort Lauderdale Alliance</span></a><span style="font-family: Times, "Times New Roman", serif;">, the Florida Department of Economic Opportunity and Enterprise Florida. The company will conduct research and development work in Coral Springs for inhalation products to treat asthma, allergic rhinitis and chronic obstructive pulmonary diseases.</span></div>
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<span style="font-family: Times, "Times New Roman", serif;">“We are delighted to be making our mark in South Florida,” Lupin CEO </span><a href="http://www.bizjournals.com/southflorida/news/2015/08/10/southflorida/search/results?q=Vinita Gupta"><span style="font-family: Times, "Times New Roman", serif;">Vinita Gupta</span></a><span style="font-family: Times, "Times New Roman", serif;"> said. “With the talent and resources this state provides, our Coral Springs expansion will further strengthen our ability to bring quality, affordable pharmaceuticals to patients in the United States and other key markets globally. The new inhalation research and development facility is a significant step forward in our journey to emerge as a global specialty pharmaceutical player.”</span></div>
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<span style="font-family: Times, "Times New Roman", serif;">Lupin is the sixth-largest generic drug manufacturer in the U.S. mart, according to IMS Health. It’s U.S. headquarters is in Baltimore. It has a pending deal to acquire New Jersey-based Gavis.</span></div>
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<span style="font-family: Times;">Source: <a href="http://www.bizjournals.com/southflorida/news/2015/08/10/lupin-pharmaceutical-firm-opens-research-center.html">http://www.bizjournals.com/southflorida/news/2015/08/10/lupin-pharmaceutical-firm-opens-research-center.html</a></span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-65795345190652436742015-08-12T08:49:00.000-07:002015-08-23T08:51:03.323-07:00Sun Pharma Q1 profit tanks 46% on Ranbaxy integration cost <div dir="ltr" style="text-align: left;" trbidi="on">
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Revenue met expectations, growing 10 percent to Rs 6,767.6 crore in June quarter compared to Rs 6,157 crore in March quarter.</h3>
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<span style="font-family: Georgia, Times New Roman, serif;">Drug major Sun Pharmaceutical Industries ' first quarter consolidated net profit disappointed street on Tuesday, down 46 percent quarter-on-quarter (down 60.2 percent year-on-year) to Rs 479 crore. The bottomline was impacted by exceptional loss, higher tax expenses and lower other income.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Revenue met expectations, growing 10 percent (up 6.7 percent on yearly basis) to Rs 6,767.6 crore in June quarter compared to Rs 6,157 crore in March quarter. Profit was estimated at Rs 894 crore on revenue of Rs 6,262 crore for the quarter, according to average of estimates of analysts polled by CNBC-TV18. Sun Pharma said net profit for the quarter was adversely impacted by one-time items related to restructuring as well as exceptional charges of Rs 685 crore. These exceptional charges related to impairment of fixed assets and goodwill and other related costs and have arisen on account of Ranbaxy integration and optimisation measures, it added. In fact, the country's largest drug maker already issued profit warning (on July 20), saying FY16 revenue will remain flat or record marginal decline compared to FY15. Hence, profit may also be adversely impacted due to certain expenses/charges arising out of Ranbaxy integration as well as remedial actions, it added.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">In fact, the country's largest drug maker already issued profit warning (on July 20), saying FY16 revenue will remain flat or record marginal decline compared to FY15. Hence, profit may also be adversely impacted due to certain expenses/charges arising out of Ranbaxy integration as well as remedial actions, it added. Branded generic sales in India (which contributes 27 percent to total sales) increased by 11 percent year-on-year to Rs 1,784 crore.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">However, US finished dosage sales fell 4 percent to USD 488 million, impacted primarily due to competitive pressure on some products and temporary supply constraints arising from remediation efforts at the Halol facility. Its US subsidiary Taro Pharma registered a 125.2 percent growth in net profit at USD 103.6 million and a 65 percent growth in revenue at USD 215 million year-on-year. However, its sales volume declined 10 percent as a result of increase in competitor activity in the US. "We remain cautious of the ever-increasing pressure on business from strong competition and the continuing industry and customer consolidations," said Kal Sundaram, Taro’s CEO on August 7. Sun's emerging markets sales dropped 15 percent on yearly basis to USD 133 million due to volatile currency movements in certain emerging markets and a strategic decision of not participating in low margin businesses. Rest of World sales declined 7 percent to USD 91 million year-on-year. Research and development investments stood at Rs 511 crore for the quarter, an increase of 37 percent over Q1 last year. This included significant investments on account of funding the clinical development of MK-3222, the IL-23 monoclonal anti-body in-licensed from MSD (US), said Sun.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Other income fell 72.4 percent to Rs 105.4 crore from Rs 382.5 crore on sequential basis. Consolidated tax expenses for the quarter were Rs 226.8 crore against tax write-back of Rs Rs 600 crore in previous quarter.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">"After the management's guidance [that its revenues would be flat for the year], the focus is on EBITDA, which is good," Sarabjit Kaur-Nangra of Angel Broking told CNBC-TV18. "But the numbers on the top line are better than our expectations."</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Operational performance was ahead of expectations. Consolidated operating profit (earnings before interest, tax, depreciation and amortisation) shot up 108.4 percent sequentially (down 4 percent year-on-year) to Rs 1,859.7 crore and margin expanded by 1300 basis points (down 310 bps year-on-year) to 27.5 percent in June quarter. Analysts were expecting operating profit at Rs 1,504 crore and margin at 24 percent for the quarter.</span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-25243246705341071662015-08-07T09:13:00.000-07:002015-08-23T09:14:47.926-07:00What Indian pharma research must learn from Sun Pharma's Glaucoma drug experience<div dir="ltr" style="text-align: left;" trbidi="on">
<span style="background-color: white; color: #3d4239; font-size: 18px; line-height: 26px;"><span style="font-family: Georgia, Times New Roman, serif;">Glaucoma is a health condition that affects the eye. It needs urgent attention and lifelong care. Left unattended, glaucoma can lead to loss of eyesight. There are no known early symptoms and the best solution is for people over 40 years to have regular eye checkups, though glaucoma could, in some rare cases, affect children too.</span></span><br />
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<span style="font-family: Georgia, Times New Roman, serif;">According to Glaucoma Society of India, Glaucoma is the third leading cause of blindness in India - 12 million people are affected accounting for 12.8 per cent of the country's blindness.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">It is a global problem. In the US, for instance, Glaucoma prevalence is reported at 1.9 per cent of the US population aged 40 or older. That means roughly 2.7 million Americans have Glaucoma.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Such patients have to be put on a dose of eye drops for life much like lifelong medication for patients of diabetes or hypertension. However, most of these eye drops tend to have side effects or other associated problems. This is because most such drops contain a preservative called Benzalkonium Chloride (BAK in quickspeak). Over time, BAK tends to prove harmful to the eye surface. In many cases, it leads to redness in the eye with symptoms like tearing, burning or itching making patients uncomfortable.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Therefore, the trend globally today is to move towards eye drops that are BAK-free. From India, Sun Pharma Advanced Research Company or SPARC has come up with a differentiated product - it is not a generic since SPARC has developed a new technology platform that avoids the use of BAK and has undertaken clinical studies in the US for this.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">It has launched a product based on this in India called Letoprost RT. However, it is facing challenges in getting the approval to launch a similar product, Xelpros, in the US market. Fortunately, as one gathers from company statements, these are not about some fundamental issues like the need for new or additional clinical data.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Between December last and August this year, SPARC received two Complete Response Letters or CRLs from the US Food and Drug Administration (USFDA), which in effect means the product application cannot be approved in its current form.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">When on December 1, 2014, SPARC announced that the FDA had issued a CRL to its New Drug Application (NDA) for Xelpros, it said: "While the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labelling and other deficiencies for processing the NDA."</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Again on August 1, 2015, it informed the bourses that it had received another CRL to its NDA for Xelpros. What is important, it said, "SPARC submitted a response to an earlier CRL it had received from the USFDA, wherein no additional preclinical or clinical data was required. While the USFDA has accepted the clarifications and changes to the labelling, SPARC has now received another CRL from the USFDA seeking minor changes to the proposed labelling. SPARC hopes to address these requirements soon."</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">First learning: It is very likely that one is not able to clearly understand what the regulator wants, and that becomes a challenge in itself. Says Anil Raghavan, CEO (R&D) at SPARC: "FDA identifies deficiencies in NDA applications and responds in the form of Complete Response Letters (CRL). The response to a CRL is based on best understanding and interpretation of the queries / comments contained in the CRL. However, FDA has the final say in determining whether a response is adequately addressing queries/comments in a CRL." It is important that Indian pharma companies doing research and seeking product approvals abroad understand this well.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Second learning: having an identical product launched in India gives you no advantage. According to SPARC, Xelpros, the product for which it is seeking approval from the USFDA is no different from Letoprost RT that it has in the Indian market. In other words, having a product in India (despite all the good reasons for a Make-in-India pitch) does not seem to be give any comparative advantage to a company planning to launch a product abroad. And it all just boils down to following the existing norm where every country has to anyway approve each product individually.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Third learning and perhaps a very important one for Indian pharma companies from the SPARC experience is with the manufacturing process that a new R&D product has to fall back on. If we are found wanting in this, even a great product development process will not help. Consider this: In the latest CRL that SPARC got from the FDA. Since the product is to be manufactured at Sun Pharma's Halol facility in Gujarat, SPARC says: "The USFDA has indicated that a satisfactory resolution of the cGMP deficiencies at this facility is a prerequisite for the final approval of Xelpros." The USFDA had observed certain cGMP deviations at this facility of Sun Pharma during the inspection conducted by the regulator in September last year.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">On the connect between Sun Pharma and SPARC on this, as many would know, in June this year SPARC licensed out XelprosTM (Latanoprost BAK-free eye drops) to a subsidiary of Sun Pharma for the US market. In addition to up-front payment of $3 million, SPARC will receive certain other milestone payments, both totalling to $16 million from Sun Pharma. It is also eligible for certain defined royalties and additional milestone payments linked to the actual sales of Xelpros</span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-48552999345158749552015-07-30T08:59:00.000-07:002015-08-23T09:00:13.906-07:00Sun Pharma may file new drug application with USFDA <div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="line-height: 12px;"><span style="font-family: Georgia, Times New Roman, serif;">India's largest drugmaker Sun Pharma may file application for a new drug with the US Food and Drug Administration in next two to three years, the company's Managing Director Dilip Shanghvi said on Thursday. The firm's research arm SPARC (Sun Pharma Advanced Research Company) is currently working on three new drugs that are currently under clinical trial stage, he added. </span></span></div>
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<span style="font-family: Georgia, Times New Roman, serif;"><span style="line-height: 12px;">"A few years back, we decided to separate our innovative business in a company called SPARC. That company has now three products undergoing clinical trials. "And hopefully in the next two to three years, we should have our own new product registered in the US," Shanghvi said in his address at Indian School of Business. </span></span></div>
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<span style="font-family: Georgia, Times New Roman, serif;"><br style="line-height: 12px; margin: 0px; outline: 0px; padding: 0px;" /></span><span style="font-family: Georgia, Times New Roman, serif;"><span style="line-height: 12px;">He, however, did not elaborate on the therapeutic areas on which those three chemical entities are under research. The company has around 1,800 research scientists working in multiple R&D centres with expertise in developing generics, difficult to make technology intensive products, Active Pharmaceutical Ingredients (APIs), Novel Drug Delivery Systems (NDDS) and New Chemical Entities (NCEs), according to SPARC's website. The company had earlier said it spends about 6 percent of its revenues on Research and Development. </span></span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-71883319455080903612015-07-25T07:59:00.000-07:002015-08-23T08:01:09.556-07:00JPMorgan to fund Lupin’s $880-million Gavis deal<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: Georgia, Times New Roman, serif;">PMorgan will bankroll <a href="http://economictimes.indiatimes.com/topic/Lupin" style="border-image-outset: initial; border-image-repeat: initial; border-image-slice: initial; border-image-source: initial; border-image-width: initial; border: 0px; color: #336797; margin: 0px 0px 10px; padding: 0px; text-decoration: none;">Lupin</a> for its $880 million acquisition of Gavis, a New Jersey-based generic drug firm.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">The Wall Street bank will act as guarantor till the date of payment, which is some weeks away, and then lend the full deal amount that Lupin will have to repay over a medium term period, said a person who is aware of the transaction</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">The loan, it's understood, is not backed by hard collateral or claims on future cashflow, but based on pure credit assessment. "Lupin will have enough time to arrange funds to pay off the loan...JP is not holding a gun to their head," said a source.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">The acquisition financing arrangement was cobbled together after the seller insisted on a guarantee.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">A spokesperson for JP Morgan India declined to comment on the deal while ET's email to a Lupin spokesperson went unanswered till the time of going to press.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">On Thursday, Lupin, a Mumbai-based pharmaceutical company, announced that it would take over Gavis, which is run by Veerappan Subramanian.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">It would be the biggest outbound transaction in the Indian pharmaceutical industry.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">JP Morgan is also the sell side advisor in the deal. "What's unusual is the absence of other bankers and JP writing the cheque for the entire amount which is not small," said a seniior banker.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Two industry sources said that Lupin had placed the bid for <a href="http://economictimes.indiatimes.com/topic/Gavis" style="border: 0px; color: #336797; margin: 0px 0px 10px; padding: 0px; text-decoration: none;">Gavis</a> and another UKbased drug firm specializing mainly in dermatological brands, which was also valued at $700-900 million.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Earlier in the year, Lupin's name had cropped up as a bidder for Kremers, the US generic drugs business of Belgian drug firm UCB.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Analysts are divided on the Gavis deal. Being valued at 9 times 2014 sales and 6 times 2015 sales, some feel it's an expensive acquisition.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Indeed, one Mumbai-based investment expert said the deal does not give comfort on the payback time, especially due to a lack of clarity on the potential upsides from the launch pipeline of Gavis. However, another analyst thinks Lupin that has paid full price for a good asset in contrast to some generic peers who typically acquire assets at distress value. "If the margins are sustained at 35% to 40%, we see Gavis to give the right push to Lupin," he said requesting anonymity.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">Lupin itself has been a conservative buyer and has not paid a very heavy price for any of its global deals.</span></div>
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<span style="font-family: Georgia, Times New Roman, serif;">On the Gavis deal, Lupin said that it hoped to leverage on at least 50 of the 66 future filings of Gavis to treble revenues by 2017-18. On Friday at the BSE, Lupin stock ended down 3% at Rs 1672.</span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-64572808667078568822015-07-25T07:56:00.000-07:002015-08-23T07:56:31.754-07:00Lupin acquires specialty portfolio from German company<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: Georgia, Times New Roman, serif;">Temmler Pharma has a specialty portfolio of 13 products including key Central Nervous System (CNS) products</span></h2>
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<span style="font-family: Georgia, Times New Roman, serif;"><span style="background-color: white; font-size: 15px; line-height: 24px;">A day after announcing a $880-million acquisition in the US, drug maker Lupin said it will acquire speciality product portfolio from German company </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Temmler+Pharma" style="background-color: white; box-sizing: border-box; color: #2591dc; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">Temmler Pharma </a><span style="background-color: white; font-size: 15px; line-height: 24px;">for an undisclosed amount.</span></span></div>
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<span style="background-color: white; font-size: 15px; line-height: 24px;"><span style="font-family: Georgia, Times New Roman, serif;">Chief executive Vinita Gupta said Temmler’s business had a “strong strategic fit with Lupin’s Hormosan business in Germany and enables Lupin to bring an enhanced specialty central nervous system (CNS) portfolio to the German market.” Established in 1917, Temmler is a part of Aenova Group, a pharmaceutical contract manufacturer. Hormosan, also a German pharmaceutical company, was acquired by Lupin in 2008.</span></span></div>
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<span style="background-color: white; font-family: Georgia, 'Times New Roman', serif; font-size: 15px; line-height: 24px;">Based in Marburg, Germany, Temmler has a specialty portfolio of 13 products including key </span><a class="storyTags" href="http://www.business-standard.com/search?type=news&q=Cns" style="background-color: white; box-sizing: border-box; color: #2591dc; font-family: Georgia, 'Times New Roman', serif; font-size: 15px; line-height: 24px; outline: 0px; text-decoration: none;" target="_blank">CNS </a><span style="background-color: white; font-family: Georgia, 'Times New Roman', serif; font-size: 15px; line-height: 24px;">products and specialty products that address rare disease areas like myasthenia gravis, huntington’s disease as well as fast-growing dermatology products for anti-wart treatment.</span></div>
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The announcement came after the close of business hours at the stock exchanges. On Friday, Lupin stock closed at Rs 1,672, down 3.27 per cent from the previous day’s close. This is the second consecutive day of decline in the stock price. On Thursday, the stock lost over five per cent after it announced a 16 per cent drop in consolidated net profit for the June quarter. The Mumbai-headquartered drug maker has lost Rs 6,844 crore of market value between Thursday and Friday owing to a drop of over eight per cent in stock price.</div>
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<span style="background-color: white; font-family: Georgia, 'Times New Roman', serif; font-size: 15px; line-height: 24px;">Earlier this week, the country’s biggest pharma company, Sun, lost over Rs 34,000 crore of market value in a day after the company said its profit will be ‘adversely impacted’ due to expenses related to integration with Ranbaxy, a company it acquired last year. </span></div>
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This is Lupin’s sixth acquisition in 18 months. In February 2014, it had acquired Netherlands-based Nanomi.</div>
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A month later, it acquired control of Mexican company Grin. In May, it bought Brazilian company Medquimica Industria Farmaceutica. Earlier this month, Lupin acquired ZAO Bio Biocom in Russia. On Thursday, it announced acquisition of New Jersey-based generic drugs firm GAVIS for $880 million. GAVIS is the largest overseas acquisition </div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-27409080179691412262015-07-24T08:13:00.000-07:002015-08-23T08:15:15.330-07:00What took mighty Lupin down! <div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="line-height: 12px;"><span style="font-family: Georgia, 'Times New Roman', serif;">I</span><span style="font-family: Georgia, Times New Roman, serif;">n an interview to CNBC-TV18, Praful Bohra, VP- Research, Religare said that US business is one of the most profitable markets for Lupin, and seeing a decline there has resulted into overall weak numbers. </span></span></div>
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<span style="line-height: 12px;"><span style="font-family: Georgia, Times New Roman, serif;">Besides, absence of big bang approvals and Aurobindo Pharmax entry into generic Suprax also impacted Lupin sales, he said. He also feels the price Lupin paid to acquire Gavis is too high. </span></span></div>
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<span style="line-height: 12px;"><span style="font-family: Georgia, Times New Roman, serif;">Below is the transcript of Praful Bohra's interview with Latha Venkatesh & Sonia Shenoy on CNBC-TV18. </span></span></div>
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<span style="line-height: 12px;"><span style="font-family: Georgia, Times New Roman, serif;">Sonia: How to approach Lupin ? </span></span></div>
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<span style="line-height: 12px;"><span style="font-family: Georgia, Times New Roman, serif;">A: The numbers were weak. On the operating front - that's largely led by the sequential decline in the US business. However, some part of it would also be driven by the entry of Aurobindo Pharma in Suprax; I think that would have led to some sequential decline. Having said that I also believe that there would be some erosion in the base business because there were no big bang approvals for Lupin in the last quarter. The US business is one of the most profitable markets for Lupin and that seeing a decline the overall numbers are weak. </span></span></div>
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<span style="line-height: 12px;"><span style="font-family: Georgia, Times New Roman, serif;">Latha: How are you looking at the Gavis acquisition? Is the price right? </span></span></div>
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<span style="line-height: 12px;"><span style="font-family: Georgia, Times New Roman, serif;">A: First on the acquisition and what it brings to the table. If you look at the portfolio of Gavis, they have a portfolio of control substances products, dermatology products where Lupin is negligibly present as of now, so that way the acquisition fits. The only thing is the price that they are paying; my sense is it is pretty expensive. So they are paying almost 9x the sales. We have seen such kind of valuations in the past only for domestic acquisitions like Ranbaxy and Abbott 's acquisition of Piramal. I think for US geography this is an expensive acquisition, much higher than what the past acquisitions have been in the range of four-five times sales. So price is one thing which I am concerned about but from a strategic perspective initially this can be return on capital employed (RoCe) dilutive in the medium-term for the company. </span></span></div>
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<span style="line-height: 12px;"><span style="font-family: Georgia, Times New Roman, serif;">It is okay portfolio wise because it fits in the strategy of Lupin but whatever the price they have paid is obnoxious.</span></span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-59872919997995962762015-06-02T21:47:00.000-07:002015-08-25T21:47:33.110-07:00Glenmark: Revenue growth in recovery mode<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="background-color: white; font-family: Georgia, 'Times New Roman', serif; font-size: 15px; line-height: 24px;">Glenmark Pharma’s revenue growth estimate of 18-20 per cent, with a 200-basis point margin expansion (excluding licensing income) for FY16 seems to have been received well by the Street. After opening below its Monday closing price (a reaction to disappointment over the company’s earnings), the stock gained ground on Tuesday, closing at Rs 861.</span></div>
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For the company, growth in revenue is expected to be driven by its US operations, likely to grow about 20 per cent. Growth of only 7.1 per cent in the US market in the March quarter, as well as one-offs and cross-currency headwinds, had led to lower than expected numbers.</div>
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Analysts at HSBC believe the FY16 estimate is realistic; they maintain a ‘buy’ rating on the stock, with a revised target price of Rs 925. Other brokerage firms such as Reliance Securities, Antique Stock Broking, IDFC Securities and Prabhudas Lilladher have higher target prices — up to Rs 1,186.</div>
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<span style="background-color: white; font-size: 15px; line-height: 24px;"><span style="font-family: Georgia, Times New Roman, serif;">The company posted almost flat (0.63 per cent) growth in US sales, which contributed about 30 per cent to its overall sales in FY15. This was due to slower approvals for new launches, even as its existing portfolio faced more competition. With six drug approvals in the past three months and more approvals expected, growth in FY16 is expected to be higher. Recent launches will have a substantial impact only in the second quarter of FY16, says Hitesh Mahida of Antique Stock Broking. Glenmark is expected to announce launches in specialty segments, particularly dermatology, which could help further, says Mahida.</span></span></div>
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<span style="font-family: Georgia, Times New Roman, serif;"><span style="background-color: white; font-size: 15px; line-height: 24px;">Glenmark filed 18 abbreviated new drug applications in FY15. Of the 95 product launches in the US, 70 are pending approvals (including 33 Para IV). Analysts at Reliance Securities foresee a smart recovery (26 per cent compounded annual growth over FY15-17) in the US, led by a pick-up in approvals and launches. The potential launches of dermatology product Azelaic acid (size $95 million), ortho ($450 million), cholesterol-lowering drug Welchol ($420 million) and Zetia ($1.7 billion) paint a healthy outlook in the US in the medium term, say analysts. The Company will launch Zetia and Azelaic acid on an exclusivity basis and analysts expect at least one of the two to be launched by December 2016. Besides, the company’s focus on complex injectables (six pending approvals), oral-contraceptives (13) and dermatology (eight) is a positive.</span></span></div>
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<span style="background-color: white; font-family: Georgia, 'Times New Roman', serif; font-size: 15px; line-height: 24px;">The company is growing well in Europe and Latin America (combined contribution about 24 per cent to revenue). In the March quarter, these growth figures stood at 26 per cent and 75 per cent, respectively. Rest-of-the-world sales (12-13 per cent of revenue), however, fell — 36 per cent in the March quarter and 18 per cent in FY15. Primarily, this was because Russia was hit by a weak currency and subdued business environment. Nevertheless, new products have been lined up for this market, too.</span></div>
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Analysts at IDFC Securities say with multiple data points expected from six ‘first in class’ clinical candidates through the next 18 months, Glenmark could generate significant licensing revenue. Successful progression of even one of these could put it in a higher growth orbit in the medium term. The company plans to utilise proceeds from the Temasek stake sale ($152 million) to reduce debt. The company’s net debt stands at $484 million.</div>
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<span style="background-color: white; font-size: 15px; line-height: 24px;"><span style="font-family: Georgia, Times New Roman, serif;">Mahida expects further improvement on this front, with Zetia’s launch-on-exclusivity, which is expected to lead to cash flow of about $150 million.</span></span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-31797755286378976342015-05-05T14:00:00.000-07:002015-09-26T14:01:19.782-07:00 USTR’s praise of Modi’s remarks worries pharma companies<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: Georgia, "Times New Roman", serif;">The United States' appreciation of Prime Minister Narendra Modi's remarks on </span><a href="http://timesofindia.indiatimes.com/topic/intellectual-property-rights"><span style="font-family: Georgia, "Times New Roman", serif;">intellectual property rights</span></a><span style="font-family: Georgia, "Times New Roman", serif;"> (IPR) has stirred concerns among the public health groups as well as the domestic drug manufacturing industry. <br /><br /> While keeping India under its 'priority watch list' in the annual report on IPR laws and patent regimes of partner countries and noting that several of its policies continue to be of grave concern, the </span><a href="http://timesofindia.indiatimes.com/topic/US-Trade-Representative"><span style="font-family: Georgia, "Times New Roman", serif;">US Trade Representative</span></a><span style="font-family: Georgia, "Times New Roman", serif;"> (USTR) has lauded Modi's recent remarks to align India's patent laws with "international standards". <br /><br /> Public health groups, advocating patient rights for access to cheaper medicines, are now concerned that this should not lead to softening of India's stand by making changes in its patent law, which has been a matter of contention between the US and Indian government for its stringent provisions. </span></div>
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<span style="font-family: Georgia, "Times New Roman", serif;"><span style="font-family: Times New Roman;">MSF, working with patients in several developing nations, said it is extremely concerned that any suggested modifications in India's IP laws will have an impact on availability of affordable medicines. <br /><br /> Another such organization, Delhi Network of Positive People, working mainly with HIV infected people around the world, has written to Modi, commerce minister Nirmala Sitharaman and health minister J P Nadda to safeguard interests of patients and not fall into the US trap to introduce IP provisions by making backdoor amendments to other laws such as the Drugs and Cosmetics Act. <br /><br /> The USTR report dubs China and India as sources of most of the counterfeit pharmaceuticals shipped to the US. "While it is impossible to determine an exact figure, studies have suggested that up to 20% of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety," the report said. <br /><br /> While refraining from imposing an out-of-cycle review (OCR) of India's IPR laws, the report lauded the efforts of the National Democratic Alliance government towards "increased bilateral engagement" between both countries in matters pertaining to IPR. <br /><br /> The report states that the US expects India to keep the momentum going, indicating expediting the rolling out of the national IPR policy, leading to "substantial and measurable improvements" in the country's IPR and patent laws. <br /><br /> However, executives of domestic pharmaceutical companies, manufacturing low cost generic medicines, say India must not fall under such pressure and instead should be cautious while making promises. <br /><br /> "We must not make concessions in our patent law. Also, policy makers need to be more cautious while dealing with bilateral issues and making strategies," said Indian Pharmaceutical Alliance secretary general DG Shah. <br /><br /> In September last year, the government here had announced it would come out with an IPR policy by early this year. For this, it has set up a taskforce under the aegis of the department of industrial policy and promotion. The final draft of the policy is now pending with the ministry of commerce. </span></span></div>
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<span style="font-family: Georgia, "Times New Roman", serif;">Source: <a href="http://timesofindia.indiatimes.com/business/india-business/USTRs-praise-of-Modis-remarks-worries-pharma-companies/articleshow/47126816.cms">http://timesofindia.indiatimes.com/business/india-business/USTRs-praise-of-Modis-remarks-worries-pharma-companies/articleshow/47126816.cms</a> </span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-431342468925048072013-08-28T14:20:00.001-07:002015-08-23T08:04:14.685-07:00Pharma Industry and Commercial Data Analytics<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhYSywaucl3YL2md4EN-N6MCXVdzlyhyphenhyphenQqzoDmhoEbC7qFby62pI8pdMkBtki6ymAKY4xlGJiFSM_rDF2RtsIKFQ_kgC6ErtgGjL8kW1pxa5GUEUmi6Vs84a0Ez__c5n_2asNK3tOh-nTk/s1600/data+analytics.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhYSywaucl3YL2md4EN-N6MCXVdzlyhyphenhyphenQqzoDmhoEbC7qFby62pI8pdMkBtki6ymAKY4xlGJiFSM_rDF2RtsIKFQ_kgC6ErtgGjL8kW1pxa5GUEUmi6Vs84a0Ez__c5n_2asNK3tOh-nTk/s1600/data+analytics.jpg" /></a></div>
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<span style="font-family: Calibri;">Ever since the fall of the
financial world in 2008, the global healthcare community has been in a unprecedented
tizzy concerning its financial expenditure with very little direction towards
salvation. The impact of this turn of events had been felt in the pharmaceutical
industry, where the price for innovation and scientific progress was
questioned. Leading pharmaceutical companies bore the brunt of the resulting promotion
of non innovative/generic drugs and increasing pricing pressure for innovative
drugs. </span></div>
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<span style="font-family: Calibri;">The pharmaceutical industry has
responded to this crisis by being more cautious in their expenditure – R&D,
promotions, sales, etc. Effective performance has been demanded from the
salesmen and marketers, and this increased scrutiny has prompted an uptake in
the usage of Analytics to make decisions at all the levels of business.</span></div>
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<span style="font-family: Calibri;">Analytics is the use of Data,
collected with intent, from processes which define a business. In the pharmaceutical
industry, the sales data (brand, geographical region, indication, line of therapy,
pack size), sale rep visits, promotional expenditure, discounts offered,
clinical data are some of the facets of business where Analytics capabilities
have been developed and used so far. The onset of field of health informatics
has enabled to analyze the demand side of the business, both for the payers and
the Pharmaceutical companies. Outcomes research and real world evidence have
gained significance for reimbursement decisions and formulary listings.</span></div>
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<span style="font-family: Calibri;">Although Analytics existed since
the onset of the industrial revolution, the current capabilities including the
big data collection and analysis has been created by the advent of information
technology. Although the promise of Analytics has been realized in various
other industries such as finance, retail and industrial production, the Pharma industry
(except the big few) has been plagued by the limitations in know-how and essential
infrastructure. Connected data processes (between manufacturer, wholesaler,
retailer, healthcare providers) are an important requirement for collection of
the data which is lacking ubiquitously in the industry.</span></div>
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<span style="font-family: Calibri;">The shortcomings in the Analytics
capabilities of the Pharma industry has given rise to a host of third party
providers who offer boutique solutions tailored to meet the needs. However
these cannot replace the company’s own capabilities due to the lack of the
overall corporate context in the outsourced set up.</span></div>
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<span style="font-family: Calibri;">Secondary research and analysis
often have a time lag of 6-8 months which relegates its importance to the
marketers. Marketing managers prefer to have fresh and dynamic inputs from the
markets rather than the static insights from secondary research. Some of the
key areas of applications of Analytics specific to the Sales, Marketing and
Strategic planning in the Pharma industry are listed below with brief
explanations</span></div>
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<span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;"><span style="font-family: Calibri;">-</span><span style="font-size-adjust: none; font-stretch: normal; font: 7pt/normal "Times New Roman";">
</span></span></span><span style="font-family: Calibri;"><b style="mso-bidi-font-weight: normal;">Optimized
marketing expenditure across customers and channels:</b> Analytics offers marketing
mix optimization using predictive analyses to suggest future best course of
action. For example a push of a button can help run analyses that optimally
allocate the total brand marketing budget across multiple internal departments
within healthcare consumers such as health care provider (HCP) sales/marketing,
consumer/patient marketing and managed markets contracting (rebates/allowances).
This method includes adding the interdependencies of the variables and can
provide ‘what if’ scenarios which offer a multidimensional view of the market.</span></div>
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<span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;"><span style="font-family: Calibri;">-</span><span style="font-size-adjust: none; font-stretch: normal; font: 7pt/normal "Times New Roman";">
</span></span></span><span style="font-family: Calibri;"><b style="mso-bidi-font-weight: normal;">Optimized
targeting of prescribers and the related investment decisions:</b> <span style="mso-spacerun: yes;"> </span>The traditional approach of identifying the
potential prescribers which is based on the historical data is passé. The
historic data can suggest only based on historical prescription habit and
cannot predict potential future leaders in prescription. Predictive Analytics
can identify attributes of high profile prescribers and help spot potential
leaders-with similar attributes-potential future prescribing leaders are
highest productive target for sales force effectiveness. Identification of
prescription patterns can also help segment the market which will help to
streamline investments in the right directions.</span></div>
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<span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;"><span style="font-family: Calibri;">-</span><span style="font-size-adjust: none; font-stretch: normal; font: 7pt/normal "Times New Roman";">
</span></span></span><span style="font-family: Calibri;"><b style="mso-bidi-font-weight: normal;">Optimize
the marketing channels, and identification of key opinion leaders:</b><span style="mso-spacerun: yes;"> </span>Information about the preferences of the
physicians about their mode of contact (mail, personal, e-mail) and frequency
of rep visit preferred also helps to increase productivity of sales rep visits.
Targeting the high value prescribers can be further improved if key opinion
leaders/top influencers in the field are identified. Social media Analytics
offers solutions which involve text mining tools scouring through <span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>the
internet to identify individuals and groups who can have a direct/indirect
impact to prescription through academic clinical research work; journal
publications and conference speaking. Following the trending individuals and
their works (studied through interdependent variables such as recent
publications in top journals, key recent conference presentations, and key incumbent
board positions) can help companies focus on the individuals with highest
impact who are the most productive targets. </span></div>
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<span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: Calibri; mso-fareast-font-family: Calibri; mso-hansi-font-family: Calibri;"><span style="mso-list: Ignore;"><span style="font-family: Calibri;">-</span><span style="font-size-adjust: none; font-stretch: normal; font: 7pt/normal "Times New Roman";">
</span></span></span><span style="font-family: Calibri;"><b style="mso-bidi-font-weight: normal;">Study the
sentiments of the patient/provider feedback and sentiments: </b>Social media Analytics
uses text Analytics and descriptive statistics to identify key sentiments
running amongst the various market segments. The interactive online initiatives
through social networking sites organized by patient support groups, healthcare
providers and patients offer an excellent opportunity for the marketers to understand
the product performance. <b style="mso-bidi-font-weight: normal;"><span style="mso-spacerun: yes;"> </span></b></span><span style="font-family: Calibri;"><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span></span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0tag:blogger.com,1999:blog-364243662451397316.post-83009835081709143622013-01-27T12:39:00.000-08:002013-08-29T02:45:58.464-07:00The grotesque side of international politics<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkGAGSmh3IAVkD6I-DHubj7YRpaRt1EtfjT96_4O5uPXJx6_8PtXJedff6sySWhMxG5ej4RnA0KmbYxh1ZMnaOjquaSLGl1EexBf7H4R81_JEth6A-FWh5jkQIfoeZG9S3lrGMRRgiydY/s1600/pharma_export.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" oea="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkGAGSmh3IAVkD6I-DHubj7YRpaRt1EtfjT96_4O5uPXJx6_8PtXJedff6sySWhMxG5ej4RnA0KmbYxh1ZMnaOjquaSLGl1EexBf7H4R81_JEth6A-FWh5jkQIfoeZG9S3lrGMRRgiydY/s1600/pharma_export.jpg" /></a></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">A peep out at international politics always throws at you distasteful human behaviour that defies ethics, rational thought and peaceful co-existence. It is a norm that one population suffers in order for another to flourish. In history, influential human beings and their directions have resulted in extreme distress for populations en masse, recent examples being that of George Bush and Osama Bin Laden; Prabhakaran and Rajapakse.<o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">What is causing distress in Iran?<o:p></o:p></span></b></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">The UN sanctions on Iran, supported by the US and its EU allies, to discourage Iran’s nuclear energy programs have led to the alienation of the nation’s commercial freedom. The international banks have been asked to sever all contact with the Iranian banks which has prevented cross-national and continental trade activities. Amidst all the chaos surrounding oil exports and curbs on banking, one silent victim has been the pharmaceutical industry. <o:p></o:p></span></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">Although the unilateral sanctions put in place by the United States and the European Union has exemptions for medicines and medical equipment, companies interested in selling such merchandise to Iran require a special license from the Treasury Department’s Office of Foreign Asset Control. However the reluctance of the banking organisations (American and European) to engage in transactions fearing backlash from the governments have discouraged the exporters to Iran. <o:p></o:p></span></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif';"><o:p> </o:p></span><b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">The healthcare problem<o:p></o:p></span></b></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">Iran has a well developed generic markets industry which produced most of the necessary drugs. However the innovative drugs which are used to treat advanced diseases are not available at this time in the market owing to the international trade alienation. The size of the Iranian market is USD 3.2 billion, of which USD 1.78 billion is generics, USD 1.13 billion is innovative drugs and USD 360 million is OTC. The market share by volume is relatively small for the innovative drugs but the higher prices have pushed up sales. <span style="mso-spacerun: yes;"> </span>Iran has a healthcare system where 90% of the population has access to healthcare provided by the government and the employers. However the weakening economy due to the drop in international oil exports is beginning to show up on the dropping healthcare expenditure. <o:p></o:p></span></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">The suffering is chiefly borne by haemophiliacs, cancer patients (particularly leukaemia), heart diseases, lung problems, and multiple sclerosis. There are currently 37000 patients of multiple sclerosis in Iran and every year 40000 patients die of cancer. International health authorities suggest that a cancer tsunami is expected by 2015, due to its high incidence in the country. <o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">Examples from the past<o:p></o:p></span></b></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">When trade sanctions happened to Iraq in the 90s, a study conducted by the Columbia school of public health, found that 225,000 children aged under five died in 8 years. This number is higher that the children killed in Hiroshima. However the US government thought that the choice was hard but the price was worth it to stabilise the Middle East.<o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">What the Iranian leaders say? <o:p></o:p></span></b></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">The Iranian leaders, are holding on to the hardline position of Iran’s Revolutionary Guard and Supreme Leader Ayatollah Ali Khamenei, who has called for the development of a “resistance economy” in order to resist the pressure by the West. However there are dissenting voices both within Iran and in the Diaspora that wants the Iranian leadership to compromise with the West. The US can promote these voices if it offers to lift some of the economic sanctions in return of curbing the nuclear advancement. However the US has so far been un-yielding.<o:p></o:p></span></div>
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<b style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">What lies ahead?<o:p></o:p></span></b></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">Iran may look at support from other willing nations for trade in pharmaceuticals. India is exploring the opportunity of drug exports to Iran despite pressure from the US in return of oil. Business will be carried out in rupee terms and not in dollar terms.<o:p></o:p></span></div>
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<i style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">Few points to ponder here.. <o:p></o:p></span></i></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif'; mso-bidi-font-family: Verdana; mso-fareast-font-family: Verdana;"><span style="mso-list: Ignore;">-<span style="font-size-adjust: none; font-stretch: normal; font: 7pt/normal "Times New Roman";"> </span></span></span><span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">Would Iran violate the TRIPS norms and engage in compulsory licensing?<o:p></o:p></span></div>
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<span lang="EN-GB" style="font-family: 'Verdana','sans-serif'; mso-bidi-font-family: Verdana; mso-fareast-font-family: Verdana;"><span style="mso-list: Ignore;">-<span style="font-size-adjust: none; font-stretch: normal; font: 7pt/normal "Times New Roman";"> </span></span></span><span lang="EN-GB" style="font-family: 'Verdana','sans-serif';">Would trade with India become a reality?<o:p></o:p></span></div>
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The Unsure Ascetichttp://www.blogger.com/profile/10196315126703878175noreply@blogger.com0